WO2011060068A1 - Canule - Google Patents

Canule Download PDF

Info

Publication number
WO2011060068A1
WO2011060068A1 PCT/US2010/056228 US2010056228W WO2011060068A1 WO 2011060068 A1 WO2011060068 A1 WO 2011060068A1 US 2010056228 W US2010056228 W US 2010056228W WO 2011060068 A1 WO2011060068 A1 WO 2011060068A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
ring
sleeve
mouth
clamp
Prior art date
Application number
PCT/US2010/056228
Other languages
English (en)
Inventor
Paul Alexander Torrie
Original Assignee
Smith & Nephew, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith & Nephew, Inc. filed Critical Smith & Nephew, Inc.
Publication of WO2011060068A1 publication Critical patent/WO2011060068A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3431—Cannulas being collapsible, e.g. made of thin flexible material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure

Definitions

  • the present invention concerns a cannula.
  • the present invention relates to a cannula that can be used to manipulate capsular tissue to reduce any obscuring of the field of view of an arthroscope which may occur.
  • a fundamental challenge when conducting arthroscopic procedures in the hip joint is the ability to maintain a good view of the working area, which is often obscured due to soft tissue from the surrounding capsule collapsing down into the joint.
  • the surgeon is somewhat restricted in their ability to prevent this from happening since the distal tip of their arthroscope can only be retracted a short distance before its field of view is occluded by the collapsing capsule.
  • the actual pathway through the capsule may be lost if the arthroscope is withdrawn too far. If this happens, the pathway then needs to be re-established and this can take a significant amount of time, as x-rays of the site are often required to assist in the re-establishment. Unnecessary damage to the capsule and surrounding tissue can also occur.
  • there are two main areas within the hip joint where this problem presents itself - the central compartment and the peripheral compartment - each associated with different reasons.
  • Access to the central compartment is generally achieved through two portal entries which pass through the capsule surrounding the joint. A cut
  • capsule is made in the capsule between the portals, and this provides the surgeon with sufficient mobility to adequately manipulate the tools which are subsequently passed down the portals.
  • the two tissue flaps of the capsule which result tend to collapse down into the joint, and obscure the surgeon's view.
  • the capsule lies very close to the femur in the region of the peripheral compartment. Therefore, when accessing the capsule in this region it is difficult manoeuvring arthroscopic instruments under the capsule and into the joint. To assist entry, surgeons will often flex the hip upwards at an angle of around 45 degrees. This helps to loosen the anterior capsule and create the required space. However, the loose capsule often fails down to obscure the surgeon's view through the arthroscope.
  • the present invention seeks to address at least some of these problems by providing a cannula that helps to prevent capsular tissue, which surrounds an access portal in which a surgical instrument is located, from collapsing in on itself when the surgical instrument is partially withdrawn from the capsule.
  • the present invention provides a cannula formed from a sleeve having a deformable mouth.
  • a cannula comprising a radially compressible sleeve having a deformable distal mouth.
  • the mouth is formed from a rigid and deformable ring.
  • the sleeve is attached to the ring around substantially its whole circumference.
  • the sleeve may be attached to the ring by any suitable means.
  • the sleeve may be passed through the ring and folded back and sealed to itself by melting or a suitable adhesive.
  • the sleeve may be rolled onto the ring and sealed as above.
  • the sleeve can be stretched and deformed in an axial direction.
  • the sleeve can be stretched and deformed in a radial direction.
  • the sleeve is formed from nylon, polyester, polyurethane, a
  • the outer surface of the sleeve has a high coefficient of friction.
  • the ring has a larger diameter than that of the sleeve.
  • the cannula is said to have an oversized mouth.
  • the cannula will be suitable for the intended purpose so long as the distal ring has a diameter which is greater than that of the portal channel and any instruments that are intended to be passed therethrough.
  • the ring is temporarily and reversibly deformable from a non- deformed first state to a temporarily deformed second state in which the diameter of the ring is reduced in at least one direction.
  • Applying a force to the ring to transform it into the temporarily deformed second state enables the mouth of the cannula to be passed through a narrow portal, which the cannula may otherwise not have been able to pass through without stretching the surrounding tissue and causing significant damage.
  • Subsequent removal of the force allows the ring to return to its non-deformed state.
  • This arrangement in which the mouth of the cannula is wider than the portal through which the cannula has been passed, helps to prevent any loose capsular tissue which surrounds the portal from collapsing around the cannula. As a result, when an arthroscope is inserted into the cannula it is much less likely to be obscured by capsular tissue, even when the arthroscope is partially withdrawn from the cannula.
  • the ring is formed from a metal or plastics material.
  • the plastics material is a polycarbonate.
  • the metal is stainless steel or another suitable metal or metal alloy.
  • the metal is a smart metal or shape memory alloy (SMA).
  • SMA is a copper-zinc-aluminium- nickel alloy, a copper-aluminium-nickel alloy, or a nickel-titanium alloy, such as Nitinot.
  • the ring is formed from a Nitinol wire.
  • the ring may be an inflatable tube.
  • the inflatable tube can be inflated and deflated in-situ.
  • the ring can be temporarily deformed into a figure-of-eight shape and folded on itself to form a pair of pseudo-concentric rings.
  • the ring can include one or more integral hinges which allow the ring to be temporarily deformed by twisting, folding, or twisting and folding.
  • the one or more hinges are formed from one or more coils that are formed integrally with the ring.
  • the mouth of the cannula includes barbs which, in use, are engageable with the capsular surface and help to prevent the cannula from being pulled out of the portal channel.
  • a cannula system according to the first aspect, wherein the cannula system further includes tensioning means.
  • the tensioning means allows any loose tissue that surrounds the portal channel on the capsular side to be actively drawn in a proximal direction and away from the joint compartment.
  • the tensioning means is a clamp.
  • the clamp is beatable towards the proximal end of the sleeve, suitably against a patient's skin.
  • the clamp includes a first ring, for inserting into the sleeve, and a second ring, for fitting over the sleeve, wherein the external diameter of the first ring is approximately equal to the internal diameter of the second ring, such that the first ring can be press-fit into the second ring to form a clamp about the sleeve.
  • the first and second rings are snap-fittable.
  • the clamp includes a tubular member and a ring.
  • the tubular member is insertable into the sleeve, and the diameter of the external circumferential surface of the tubular member is substantially equal to the diameter of the internal circumferential surface of the ring, such that when the ring is fitted over the tubular member with the sleeve located therebetween, they form a clamp about the sleeve.
  • the ring includes a hinge and clasp or lock.
  • the tubular member has an external diameter that approximately equal to the internal diameter of the sleeve.
  • the tubular member has an external diameter that is greater than the internal diameter of the sleeve - this has the effect of stretching the sleeve in an radial direction when the tubular member is inserted therein.
  • an internal circumferential surface of the ring includes a gasket.
  • the gasket is at least partially formed from a rubber or plastics material
  • the gasket helps to prevent slippage of the sleeve between the c!amp to maintain any tension in the sleeve of the cannula.
  • the sleeve may be clamped to a conventional cannula which has been inserted into the cannula of the invention. This may be by any suitable means, such as a conventional clasp, clamp or rubber ring.
  • a proximal region of the sleeve may include one or more holes, optionally reinforced around their circumferences, which can be pulled over a post located on a conventional cannula.
  • the sleeve includes at least several such holes which allow the sleeve to be tensioned irrespective of the length of the portal channel and engaged with a feature on the cannula.
  • the sleeve does not include holes and a cap or ring is used to trap the sleeve over a post of the conventional cannula.
  • tensioning the sleeve and clamping it proximally is that the collapsible cannula can be used to draw capsular tissue away from the surgical site. This helps to provide a clear view of the joint compartment when using an arthroscope.
  • the clamp may also comprise a collar, through which the proximal end of the sleeve may be drawn, and a cap or plug which can be placed into the end of the collar to wedge the sleeve therebetween, wherein the cap or plug includes a central aperture which provides access to the cannula.
  • the cap or plug may be push-fittable into the collar, or engage with a groove or thread on the collar.
  • the cannula system further comprises an inserter for inserting the cannula into a portal channel leading to a joint compartment.
  • the inserter is a rod which is engageable with the mouth of the cannula and which allows it to be pushed through a conventional cannula which has been inserted into the portal channel.
  • the inserter includes means for engaging the mouth of the cannula so that the inserter does not prematurely detach therefrom.
  • the inserter may comprise a snap-fit arrangement with the mouth of the cannula.
  • the inserter comprises a tube within which the cannula is preloaded, and a rod as described above.
  • the tube is inserted into the portal channel and the rod is used to engage the mouth of the cannula to drive it distal!y from the tube.
  • the tube and rod are withdrawn leaving the cannula in the portal channel with its distal mouth in the joint compartment.
  • the rod may be left within or alongside the sleeve, within the portal channel, in order to assist with the removal of the cannula once the surgical procedure has been completed.
  • the proximal end of the sleeve may be detachably clamped at or in the region of the proximal end of the inserter, or the conventional cannula.
  • one or more sutures or reinforcements may be attached at the distal region of the cannula or to the mouth. These help to facilitate removal of the cannula from a surgical site.
  • Figures 1 A-E are schematic sectional side views of an embodiment of a
  • cannula according to the invention, illustrating a first method of introducing the cannula into a portal channel, and its subsequent removal;
  • Figure 2 is a cannula engaged with an inserter rod;
  • Figures 3A & B are, in perspective and sectional views, the cannula of Figure 2 fitted with a clamp;
  • Figures 4A-C are schematic perspective views of the cannula mouth and
  • Figures 5A-C are perspective views of a distal ring used for forming the
  • Figures 6A & B are schematic sectional side views of the cannula of Figure 1 with a conventional cannula located therein;
  • Figure 7 is a perspective view of the cannula of Figure 1 , together with a proximal needle clamp;
  • Figures 8A-C are schematic sectional side views of an alternative clamp
  • Figure 9 is a schematic sectional side view of a further alternative clamp
  • Figures 10A-J are schematic sectional side views illustrating an alternative method of introducing a cannula of Figure 1 into a portal channel, and its subsequent removal;
  • Cannula 0 is formed of a sleeve 12 and a deformable mouth 13.
  • the deformable mouth 13 is formed from a rigid and deformable ring, discussed in greater detail below in relation to Figures 5A-C.
  • Sleeve 12 is a radially compressible tube formed from a nylon, polyester, polyurethane, a fluoropolymer such as polytetrafluoroethylene, or a layered composite of one or more of these materials. It is desirable that the outer surface of the sleeve has coefficient of friction that is greater than that of the portal channel.
  • Sleeve 12 is attached to the ring of mouth 13 by passing the distal end of the sleeve through the ring, folding back the sleeve and then rolling the ring proximally a short distance back up the sleeve.
  • the sleeve is then either sealed to itself with adhesive, or by melting.
  • the ring and sleeve may be attached together by any suitable means.
  • the sleeve can be stretched and deformed in both radial and axial directions.
  • cannula 10 is shown pre-loaded within an inserter in the form of a tube 11 , with the mouth 13 of the cannula presented in a deformed or flattened configuration.
  • Figure 1 B shows the cannula 10 after it has been deployed within a portal channel 14, and tube 11 has been removed.
  • tube 1 1 is located within the portal channel so that its distal end just sits outside the portal channel, and within the joint compartment (not shown).
  • a rod 20 is then used to push against mouth 13 to drive the distal region of the cannula 10 from the inserter tube.
  • the forces which act to deform it are removed and it expands to a non-deformed state in which the mouth overlaps the edges of the portal channel within the compartment.
  • the inserter tube is then carefully removed from the portal channel, leaving the cannula 10 in place, as shown in Figure 1B. Since the cannula 10 of the invention is compressible, the tissue surrounding the portal channel naturally collapses against the sleeve to partially seal the channel and minimizes any fluid loss from the compartment.
  • the rod 20 may be left engaged with the mouth of the cannula to facilitate guidance of a conventional cannula 15 down the interior of the compressed cannula.sleeve 12 as shown in Figures 1 C and 1D.
  • the mouth Since the mouth's unrestrained shape is larger than the portal channel through the capsule from which it was delivered, the mouth resists the cannula from being pulled proximally up through the portal channel, and helps to prevent the mouth of the portal channel from collapsing around the tip of the conventional cannula 15. This is particularly important when the conventional cannula includes an arthroscope as it helps to prevent restriction in the field of view of the
  • Figure 1 E illustrates a means of removing cannula 10 from the portal channel by pulling on one side of the sleeve towards the proximal end of the cannula, in order to deform the mouth 13 and allow it to be pulled in to the portal channel.
  • Figure 2 there is shown a cannula 10 fitted with an alternative inserter, or rod 20.
  • the sleeve is shown in an expanded configuration.
  • Rod 20 includes, at its distal end, means for engaging the mouth 13 of cannula 10 and sleeve-engaging means 21 at its proximal end.
  • the sleeve-engaging means 21 is a tab or projection which engages with an aperture in the region of the proximal end of the sleeve (see Figure 2).
  • a rod is used to push the distal ring of mouth 13 down an inserter tube, or a conventional cannula, and may be removed after the mouth exits the distal tip of a conventional cannula .
  • the mouth typically has a diameter of around 25 - 50 mm, and must compress while traversing the relatively small diameter cannula (4 - 10 mm) then expand into its natural state which is roughly circular after it exits the cannula under the capsule.
  • a clamp22 which is designed to be slipped over cannula 10 and brought against the skin.
  • Sleeve 12 is tensioned until the joint space can be adequately visualised, by means of an arthroscope placed within the same portal, or a different portal, and the clamp fastened to the sleeve. Further sleeve tensioning may be carried out once the clamp is in place, allowing proximal sleeve motion but no distal motion.
  • the illustrated clamp includes a first clamp ring 23, that is slid within the cannula sleeve, and a second clamp ring 24 which is slid over the exterior of the cannula sleeve and down to the skin, distal to the first clamp ring 23.
  • FIGS 4A-C show various suture arrangements attached at the mouth 13 of cannula 10 which, when pulled, help to collapse the ring of the mouth. This allows the cannula to be drawn proximally into the portal channel during extraction of the cannula .
  • a suture 30 is shown attached to the distal ring of mouth 13. In the embodiments shown, the suture runs the length of and is housed within the cannula.
  • the suture is located outside of the cannula sleeve.
  • the suture may be attached at locations adjacent to or opposite a purposely weakened region of the distal ring, for example, the ring may include a region of reduced thickness which is more easily deformed. Other examples will be discussed below in relation to Figures 5A-C. Attaching the suture adjacent to or opposite such a weakness allows the ring to collapse more easily in response to a proximal pulling force on the suture.
  • the suture or sutures may be attached at single sites, as shown in Figure 4A, or at multiple positions, as shown in Figures 4B & C. Additionally, stopper knots 31 or similar means, can be placed on the suture or reinforced area near their distal end such that they run up against a feature in the distal ring and then transmit the pullout force to the distal ring. Thus, the retrograde force is used first to bend the distal ring to a collapsed state and then to withdraw the ring into the portal channel.
  • Figures 5A and C show an example of a distal ring 32 in non-deformed and deformed states, respectively.
  • the ring 32 is formed from a super elastic material such as Nitinol which allows recovery from large deformations.
  • the shape of the unstressed distal ring is preferably a hoop to resist compression but it may have other shapes, such as an oval or square shape.
  • the shapes are typically closed or continuous, but have an open structure in alternative embodiments.
  • the ring is formed from a plastics material such a polycarbonate.
  • the ring is an inflatable tube.
  • the inflatable tube can be inflated in a closed system, or can be inflated or deflated through an appropriate valve and by means of a suitable gas or fluid source.
  • a particular advantage of an inflatable and deflatable system is that the diameter of the un-inflated cannula is generally smaller than that of a cannula which has a mouth formed from a metal or plastics ring.
  • the distal ring may also include a hinge or joint 33.
  • the hinge may be in the form of one or more continuous loops that are formed integrally with distal ring 32.
  • this joint preferably is rigid, and the distal ring contains two hinges 33 which allow the ring to deform significantly ( Figure 5C) and still recover its shape once the deforming force has been removed.
  • having two coils 180° apart allows the distal ring to deform into a relatively long yet narrow cylindrical envelope such as an inserter tube.
  • the stress reducing coils may have a single ring, but in alternative embodiments include more than one coil.
  • Figures 6 A + B show a cannula 10 located within a portal channel, with a conventional cannula 15 and arthroscope 34 inserted therein. The
  • conventional cannula 15 includes a spacer ring 35 which has an outer diameter approximately equal to that of the inner diameter of the sleeve 12.
  • Spacer ring 35 provides a snug fit against the conventional cannula and acts to prevent fluid loss from the surgical site.
  • the sleeve 12 is clamped to conventional cannula 15 by means of a clamping ring 40 which captures the sleeve around a post 41 of the cannula.
  • FIG. 7 An alternative clamp is shown in Figure 7, which comprises spike or needle 43 which passes through sleeve and rests on the patient's skin.
  • Figures 8A- 8C show a further alternative embodiment for a skin clamp 44.
  • the sleeve 12 is pulled through the clamp and is tensioned with the clamp positioned against the skin and surrounding the collapsed sleeve ( Figure 8A).
  • the clamp 44 is then squeezed shut forcing the one or more spikes 45 through both sleeve walls and into a receiving portion of the clamp.
  • the cannula sleeve is then spread apart to receive the cannula or other surgical instruments.
  • the clamp has a preferably linear action but may also be hinged.
  • Clamp 50 can be used to squeeze sleeve cannula sleeve 12 to prevent fluid outflow.
  • the internal joint pressure created by a pump (not shown) or gravity forces the cannula mouth 13 against the capsule 51 to seal the joint from further leakage.
  • FIGS 10A to 10J illustrate an alternative insertion and extraction procedure using an insertion rod and a conventional cannula 15.
  • a conventional cannula 15 is introduced into the portal channel ( Figure 10A).
  • a surgical blade may be introduced into the cannula 15 in order to perform a capsulotomy ( Figure 10B) which provides the surgeon with more space in which to manipulate his surgical tools which are subsequently passed down the portals.
  • a cannula 10 of the invention is introduced down the conventional cannula 15 using a rod 20 to push cannula mouth 3 beyond the mouth of the conventional cannula, which is subsequently retracted.
  • rod 20 may be detached from the cannula mouth 13 and withdrawn from cannula 10. Alternatively, it can be left in-situ to act as a guide for insertion of a further conventional cannula 15' ( Figure 10G), and also to assist in the removal of cannula 10 once the surgical procedure has been completed.
  • the cannula 10 is tensioned and a clamp attached at its proximal end ( Figure 0F). This has the effect of drawing loose capsular tissue back and prevents it from falling into the compartment, in the vicinity of the cannula 10.
  • the cannula can be removed as previously described in relation to Figure 1 , or the rod can be used to assist in its removal (not shown).

Abstract

La présente invention a pour objet une canule (10) formée à partir d'un manchon (12) ayant un bec déformable (13). La présente invention concerne également un système de canule.
PCT/US2010/056228 2009-11-10 2010-11-10 Canule WO2011060068A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25974409P 2009-11-10 2009-11-10
US61/259,744 2009-11-10

Publications (1)

Publication Number Publication Date
WO2011060068A1 true WO2011060068A1 (fr) 2011-05-19

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PCT/US2010/056228 WO2011060068A1 (fr) 2009-11-10 2010-11-10 Canule

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WO (1) WO2011060068A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5480410A (en) * 1994-03-14 1996-01-02 Advanced Surgical, Inc. Extracorporeal pneumoperitoneum access bubble
US5895351A (en) * 1998-02-06 1999-04-20 Arthrotek Inc. Tissue distracting cannula
US6171282B1 (en) * 1999-07-23 2001-01-09 Edgar K. Ragsdale Soft cannula and methods for use
US20060229501A1 (en) * 2005-03-31 2006-10-12 David Jensen Surgical hand access apparatus
US20060247498A1 (en) * 1998-12-01 2006-11-02 Frank Bonadio Instrument access device
US20070123798A1 (en) * 2005-10-07 2007-05-31 Tsion Israel Medical Systems Ltd. Contamination protection device and method for use
US20090182288A1 (en) * 2008-01-04 2009-07-16 Spenciner David B Flexible Medical Cannula
US20090221966A1 (en) * 2008-03-03 2009-09-03 Tyco Helathcare Group Lp Single port device with multi-lumen cap

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5480410A (en) * 1994-03-14 1996-01-02 Advanced Surgical, Inc. Extracorporeal pneumoperitoneum access bubble
US5895351A (en) * 1998-02-06 1999-04-20 Arthrotek Inc. Tissue distracting cannula
US20060247498A1 (en) * 1998-12-01 2006-11-02 Frank Bonadio Instrument access device
US6171282B1 (en) * 1999-07-23 2001-01-09 Edgar K. Ragsdale Soft cannula and methods for use
US20060229501A1 (en) * 2005-03-31 2006-10-12 David Jensen Surgical hand access apparatus
US20070123798A1 (en) * 2005-10-07 2007-05-31 Tsion Israel Medical Systems Ltd. Contamination protection device and method for use
US20090182288A1 (en) * 2008-01-04 2009-07-16 Spenciner David B Flexible Medical Cannula
US20090221966A1 (en) * 2008-03-03 2009-09-03 Tyco Helathcare Group Lp Single port device with multi-lumen cap

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